MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-30 for HU-FRIEDY MFG. CO., LLC SBH5/6C8 manufactured by Hu-friedy Mfg. Co., Llc.
[56096080]
Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number or udi, only by a lot number, which is tied to the date of manufacture. The product involved in the event does not have an expiration date. The device is not implanted, therefore implant/explant dates are not applicable.
Patient Sequence No: 1, Text Type: N, H10
[56096081]
The tip of the instrument broke off in the patient's mouth.
Patient Sequence No: 1, Text Type: D, B5
[58465181]
Follow-up report: on (b)(6) 2016, the patient's mother called the (b)(6) to report that the patient had passed the tip. Updated fields: the patients age has been updated. The date of event has been updated. Patient's relevant history has been updated. The operator of the device has been updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2016-00007 |
| MDR Report Key | 5992317 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-30 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-08-30 |
| Date Mfgr Received | 2016-09-01 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2016-09-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARIA VRABIE |
| Manufacturer Street | 3232 N ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7738685676 |
| Manufacturer G1 | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Street | 3232 N ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY MFG. CO., LLC |
| Generic Name | CURETTE |
| Product Code | EMS |
| Date Received | 2016-09-30 |
| Model Number | SBH5/6C8 |
| Catalog Number | SBH5/6C8 |
| Lot Number | 0712 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | 3232 N ROCKWELL ST. CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-30 |